Determining the Effect of Montelukast in Reducing the Reducing of the Disease in Patients with Moderate to Severe Ulcerative Colitis Referred to the IBD Clinic in Tabriz during the Tapering of Glucocorticoid Dose

Abstract

Considering the role of leukotrienes in inflammatory pathways, and owing to the anti-leukotrienes effect of Montelukast, in the present clinical trial, we aimed to assess the effect of Montelukast on remission maintenance in patients with ulcerative colitis (UC). Methods: In the present double-blind randomized controlled clinical trial, 222 volunteer UC patients who were on high -dose corticosteroid and Mesalamine for flare-up management, were recruited. The patients received 10 mg of Montelukast or a placebo for 16 weeks. Simultaneously, the prednisolone dose was tapered. The patients were followed up six more weeks post-interventions. The primary efficacy of the treatment was remaining in remission. Results: During study, relapse was occurred in 108 patients, 32 patients in Montelukast group and 76 patients in the placebo group. There were significant differences between groups regarding relapse-free period between the intervention group (mean: 27.25 95% CI: 26.17-28.32 weeks) and the placebo group (mean: 20.88; 95% CI: 19.36, 20.40 weeks), (P<0.001). At the end of the intervention period and six weeks’ post-intervention, the mean partial mayo score, and inflammatory biomarkers were significantly lower in the Montelukast group compared with the placebo group. The frequency of patients with high fecal protecting levels was significantly higher in the placebo group compared with the ML group.